FEATURED EDITORIAL
Instead of automating everything — which costs a lot and doesn't solve every problem — drug makers should focus on building scalable, need-specific supply chain operations. This article discusses supply chain resilience strategies biotech companies can reasonably control.
- Considerations For Microbial Enumeration Methods When Working With CDMOs
- The Promise Of Outcomes-Based Agreements For Cell & Gene Therapies
- CDMO Performance, The Workforce, And Reshoring
- The Holistic Guide To Supply Chain For Cell & Gene Therapy Startups
- EMA's Revised GMP Annex 1 Addresses Common Global Challenges for Sterile Products
- FDA Releases Final Guidance On Early-Phase Cell & Gene Therapy Trials
- Revision Of The ASTM E3263 Standard For Visual Inspection Of Pharmaceutical Manufacturing Equipment And Medical Devices For Residues
GUEST COLUMNISTS
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The Promise Of Outcomes-Based Agreements For Cell & Gene Therapies
There is a pressing need for stakeholders to find cost-effective ways to help more patients gain access to cell and gene therapies. While many types of innovative payment models exist, outcomes-based agreements — in which manufacturers and payers agree to specific performance and outcome metrics — are emerging as an attractive best practice option for both parties.
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The Holistic Guide To Supply Chain For Cell & Gene Therapy Startups
How does the cell and gene therapy supply chain team stay ahead of the expected changes and respond at the speed the developing program expects? Supplier selection, raw materials, built-in quality, warehousing and logistics, and traceability are all covered in this article.
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EMA's Revised GMP Annex 1 Addresses Common Global Challenges for Sterile Products
The new EMA GMP Annex 1, “Manufacture of Sterile Medicinal Products," is in line with other international regulations, e.g., ICH and PIC/S. FDA involvement in its writing is a clear indication that the contents will be the FDA position in general terms. Fortunately, the annex contains many checklists to help you assess and remedy your systems.
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FDA Releases Final Guidance On Early-Phase Cell & Gene Therapy Trials
The cell and gene therapy development process involves screening different variants of a product type. To aid this process and to ensure that suitable evidence is gathered so that effective variants of the product are taken through to later-stage trials, the FDA has produced a final guidance, Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial.
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Revision Of The ASTM E3263 Standard For Visual Inspection Of Pharmaceutical Manufacturing Equipment And Medical Devices For Residues
ASTM has published the revision of ASTM E3263 "Standard Practice For Qualification Of Visual Inspection Of Pharmaceutical Manufacturing Equipment And Medical Devices For Residues.” This article, written by the ASTM revision team itself, explains the reasons behind the revision and delves into the key updates.
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The Best CDMOs Are Redundant
The top CDMO-selection criteria for Perry Calias, Chief Operations Officer, Revolo Biotherapeutics, and a veteran outsourcer, is redundancy. Redundancy laced with relationships, that is. Here's how it can work for you.
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Defining The RNA Therapeutics Industry In 2023
Four executives outline which industry challenges, strategic considerations, and opportunities should be top of mind as RNA therapeutics companies establish their to-do lists for 2023.
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Frequent Deficiencies In GMP Inspections, Part 3
Don't let cleaning and disinfection methods work against you. Without a system to track cleaning chemicals and equipment, how do you know they haven't expired?
PHARMA OUTSOURCING WHITE PAPERS
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Rational Design & Development Of Lipid- Filled Hard Capsules
With the increasing percentage of water-insoluble or low permeable new therapeutic entities among drug pipelines, lipid-based drug delivery systems have become an important tool for formulation development.
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CDMO Collaboration: Foundation For Sterile Injectable Product Success
Explore how a small or medium size biotech or pharma company eveloping sterile injectables can benefit from the experience and assistance provided by a CDMO.
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Bulletproof Supply Chain: Hope For The Best, Prepare For The Worst
How to incorporate flexibility in planning to overcome potential challenges, the value of having a contingency plan, and how a risk-based approach can determine where a contingency plan is needed.
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Understanding FDA Guidance For Pediatric Oncology Studies
Learn how the Research to Accelerate Cures and Equity (RACE) for Children Act aims to improve and expand treatment options for pediatric cancer patients.
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Nanosuspension Dosage Forms: Product Development & Scale Up
For drug nanosuspensions, parameters like stabilizer concentration, drug loading, milling speed, milling time, bead diameter/density, and temperature are important formulation and process variables.
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Strategies For Accelerating The Development Of Modified Release Oral Forms
Careful selection of appropriate excipients and delivery technologies is key to the design of modified release (MR) formulations fulfilling specific performance requirements.
PHARMA OUTSOURCING APP NOTES & CASE STUDIES
- Achieving Shorter Production Time For A Pancreatic Cancer Drug
- Analytical Quality By Design Based Method Development For The Analysis Of Valsartan And Nitrosamines Impurities Using UPLC-MS
- Former FDA Chief Talks COVID-19 Vaccine Future At Process Progress
- Scale From Cell Factory Systems To A Bioreactor Without Affecting CQAs
- Maximizing Yield And Minimizing Risk In Aseptic Filling
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CONTENT COLLECTIONS

The “Outsourcing Master Class” is a capstone-case-review, team-based course sanctioned by the International Association of Outsourcing Professionals (IAOP). Designed by Darren Dasburg, Chief Business Officer, CRISPR Biotech, these time-tested outsourcing fundamentals offer you a blueprint to keep teams working together on both sides.
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